Ignite Creation Date:
2024-05-06 @ 3:54 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02406963
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2015-03-23
Brief Title:
Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
Sponsor:
McMaster Childrens Hospital
Organization:
McMaster Childrens Hospital
Study Overview
Official Title:
Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A pilot research study is planned to occur within the pediatric urology service the spring of 2015 All pediatric urology patients in the immediate post-operative period of 0-14 days will be eligible for this study This study will compare the current standard of care for managing post-operative complications a telephone conversation with the NP versus an experimental intervention telephone call and an electronic photograph of the surgical site Before the surgical patient is discharged from the hospital consent will be obtained for participation Once a family initiates contact with the NP with a post-operative concern they will be randomized to either the control or the experimental group Those in the control group will receive the current standard of care which is telephone advice only Those in the experimental group will speak to the NP on the telephone and will be requested to send an electronic photograph of their childs surgical site to the NP for assessment and advice Photographs will be assessed using a standardized tool by both NPs and this information will be entered into a database The investigators will be measuring the number of emergency department ED andor unplanned clinic visits in both groups An unplanned clinic visit is defined as a visit that is required due to an unexpected complication or concern before the original scheduled post-operative follow-up as determined by the surgeon The investigators will be tracking the number of follow-up phone calls for both groups as well as requiring participants to complete a familypatient experience survey after speaking to the NP
Detailed Description:
This study design will be a pilot randomized controlled trial Consent for this study will be obtained within the circle of care immediately before the patient is discharged home following surgery The families will be instructed to contact the NP by telephone with any post-operative questions or concerns they have about their child Once the family initiates contact with the NP they will be randomized into either the experimental PEC group or the control TTC group
Once randomization has occurred the NP will obtain all necessary information from the parent by addressing all points in expertise based script developed by the Pediatric Urology Team for both groups Those randomized to the control group TTC will be provided recommendations based on information obtained during the standard telephone call Families who are randomized into the PEC experimental group will be required to send a digital photograph of the childs surgical site to the professional email address of NP Should they agree to send digital photographs they will be required to give consent for email correspondence which will be emailed to them by the NP Once they have consented they may send digital photographs to the NP of their childs surgical site which will be assessed by both NPs using an expertise-based assessment tool This information will be entered into REDCap The NPs will come to a unanimous decision regarding advice to be provided and this will be communicated to the parents Upon completion of the interaction with the NP the RA will contact the family to complete the familypatient experience survey over the telephone Familypatient experience will be measured using an adapted validated tool Nurse Practitioner Satisfaction Survey consisting of 10 questions directly related to telephone interaction with the NP This survey consists of a Likert Scale with scores ranging from 1-5 with 5 being the most positive response Follow up telephone calls for both groups will be logged in MediTech as well as the RedCAP database All telephone calls will be documented within the MediTech system and included in patients chart in order to maintain current standard of care All digital photos will be printed and placed in the patients chart and deleted from the email server which is the current process for those engaging in PEC
Recruitment for this study will occur for 7 months with the aim of recruiting 40 patients per arm in order to obtain the feasibility data However a sample size calculation has been carried out and assuming 75 power and an alpha error of 5 using a one sided test the required sample size to answer the definitive research question is 114 patients per group
Data will be analyzed by comparing the number of ED and unplanned clinic visits for both groups as well as the number of follow up phone calls received This will be done using descriptive statistics and a t-test for independent means Familypatient experience will also be measured between the two groups PEC and TTC using descriptive statistics and a t-test for independent means Subgroup analysis will be done to determine which subgroup of post-operative patients benefit most from PEC ie penile surgeries
Once randomization has occurred the NP will obtain all necessary information from the parent by addressing all points in expertise based script developed by the Pediatric Urology Team for both groups Those randomized to the control group TTC will be provided recommendations based on information obtained during the standard telephone call Families who are randomized into the PEC experimental group will be required to send a digital photograph of the childs surgical site to the professional email address of NP Should they agree to send digital photographs they will be required to give consent for email correspondence which will be emailed to them by the NP Once they have consented they may send digital photographs to the NP of their childs surgical site which will be assessed by both NPs using an expertise-based assessment tool This information will be entered into REDCap The NPs will come to a unanimous decision regarding advice to be provided and this will be communicated to the parents Upon completion of the interaction with the NP the RA will contact the family to complete the familypatient experience survey over the telephone Familypatient experience will be measured using an adapted validated tool Nurse Practitioner Satisfaction Survey consisting of 10 questions directly related to telephone interaction with the NP This survey consists of a Likert Scale with scores ranging from 1-5 with 5 being the most positive response Follow up telephone calls for both groups will be logged in MediTech as well as the RedCAP database All telephone calls will be documented within the MediTech system and included in patients chart in order to maintain current standard of care All digital photos will be printed and placed in the patients chart and deleted from the email server which is the current process for those engaging in PEC
Recruitment for this study will occur for 7 months with the aim of recruiting 40 patients per arm in order to obtain the feasibility data However a sample size calculation has been carried out and assuming 75 power and an alpha error of 5 using a one sided test the required sample size to answer the definitive research question is 114 patients per group
Data will be analyzed by comparing the number of ED and unplanned clinic visits for both groups as well as the number of follow up phone calls received This will be done using descriptive statistics and a t-test for independent means Familypatient experience will also be measured between the two groups PEC and TTC using descriptive statistics and a t-test for independent means Subgroup analysis will be done to determine which subgroup of post-operative patients benefit most from PEC ie penile surgeries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None